EP3773407B1 - Gastrointestinales behandlungssystem mit einer vibrierenden kapsel und verfahren zu dessen verwendung - Google Patents

Gastrointestinales behandlungssystem mit einer vibrierenden kapsel und verfahren zu dessen verwendung

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Publication number
EP3773407B1
EP3773407B1 EP19774489.9A EP19774489A EP3773407B1 EP 3773407 B1 EP3773407 B1 EP 3773407B1 EP 19774489 A EP19774489 A EP 19774489A EP 3773407 B1 EP3773407 B1 EP 3773407B1
Authority
EP
European Patent Office
Prior art keywords
day
capsule
time
seconds
subject
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19774489.9A
Other languages
English (en)
French (fr)
Other versions
EP3773407C0 (de
EP3773407A1 (de
EP3773407A4 (de
Inventor
Lior BEN-TSUR
Shai MOLNAR
Roni Shabat
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vibrant Ltd
Original Assignee
Vibrant Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GBGB1805325.6A external-priority patent/GB201805325D0/en
Priority claimed from GBGB1808859.1A external-priority patent/GB201808859D0/en
Application filed by Vibrant Ltd filed Critical Vibrant Ltd
Publication of EP3773407A1 publication Critical patent/EP3773407A1/de
Publication of EP3773407A4 publication Critical patent/EP3773407A4/de
Application granted granted Critical
Publication of EP3773407C0 publication Critical patent/EP3773407C0/de
Publication of EP3773407B1 publication Critical patent/EP3773407B1/de
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/07—Endoradiosondes
    • A61B5/073—Intestinal transmitters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6861—Capsules, e.g. for swallowing or implanting
    • A—HUMAN NECESSITIES
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
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    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
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    • A—HUMAN NECESSITIES
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    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive
    • A61H23/0254—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor
    • A61H23/0263—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive with rotary motor using rotating unbalanced masses
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
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    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5005—Control means thereof for controlling frequency distribution, modulation or interference of a driving signal
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5007—Control means thereof computer controlled
    • A61H2201/501—Control means thereof computer controlled connected to external computer devices or networks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5023—Interfaces to the user
    • A61H2201/5025—Activation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5023—Interfaces to the user
    • A61H2201/5035—Several programs selectable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5064—Position sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5071—Pressure sensors
    • A—HUMAN NECESSITIES
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5082—Temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
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    • A61H2201/5084—Acceleration sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
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    • A61H2201/5058—Sensors or detectors
    • A61H2201/5092—Optical sensor
    • A—HUMAN NECESSITIES
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5097—Control means thereof wireless
    • A—HUMAN NECESSITIES
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/08—Trunk
    • A—HUMAN NECESSITIES
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/08—Trunk
    • A61H2205/083—Abdomen
    • A—HUMAN NECESSITIES
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    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2230/00—Measuring physical parameters of the user
    • A61H2230/50—Temperature
    • A61H2230/505—Temperature used as a control parameter for the apparatus

Definitions

  • the present invention relates in general to gastrointestinal treatment systems including one or more vibrating capsules, and more particularly, to gastrointestinal treatment systems in which the one or more capsules vibrate, or are adapted to vibrate, at one or more specific times of day.
  • the present invention further relates in general to a system for mitigating at least one effect of jetlag, and specifically to mitigating jetlag using a gastrointestinal treatment system including one or more vibrating capsules.
  • Document CN 106 377 406 A discloses a device according to the preamble of claim 1.
  • a gastrointestinal treatment system including a gastrointestinal capsule as set forth in claim 1 of the appended claims.
  • the capsule is adapted to be in the operative state following receipt of an activation input, which transitions the capsule from an inoperative state to an operative state.
  • the subject is travelling from an origin location to a destination location, and the system is adapted to mitigate jetlag of the subject.
  • control mechanism is adapted to activate the vibrating agitation mechanism to operate in the first vibrating mode of operation at at least one predetermined time of day according to a time zone of the origin location.
  • control mechanism is adapted to activate the vibrating agitation mechanism to operate in the first vibrating mode of operation at at least one predetermined time of day according to a time zone of the destination location.
  • control mechanism is adapted to activate the vibrating agitation mechanism to operate in the first vibrating mode of operation at a first time of day of the at least one predetermined time of day according to a time zone of the origin location and at a second time of day of the at least one predetermined time of day according to a time zone of the destination location.
  • the predetermined time of day is selected according to a circadian cycle of the subject.
  • the predetermined time of day is selected according to a gastric pH profile of the subject.
  • the capsule includes at least one timing mechanism, and is devoid of sensors for sensing an environment thereof.
  • control mechanism is adapted, in response to the activation input, to wait a predetermined delay time, and following the predetermined delay time, at a time coinciding with the at least one predetermined time of day, to activate the vibrating agitation mechanism to operate in the first vibration mode of operation.
  • the capsule further includes at least one sensor adapted to provide the activation input.
  • the at least one sensor includes an illumination sensor adapted to provide the activation input upon identification of transition of the capsule from an illuminated environment to a dark environment.
  • the at least one sensor includes a pressure sensor adapted to provide the activation input upon identification of pressure applied to the capsule, which pressure is indicative of the capsule moving through a pharynx of the subject.
  • the at least one sensor includes a temperature sensor adapted to provide the activation input upon identification of transition of the capsule from an area with ambient temperature to an area with a human body temperature.
  • the at least one sensor includes an accelerometer adapted to provide the activation input upon identification of an activation motion carried out by a user of the gastrointestinal capsule.
  • the at least one sensor includes a moisture sensor adapted to provide the activation input upon identification of transition of the capsule from a dry environment to a humid environment.
  • the capsule further includes a timing mechanism, wherein in response to the activation input, the control mechanism is adapted to activate operation of the timing mechanism to track a time of day so as to identify the at least one predetermined time of day for activation of the vibration agitation mechanism.
  • system further includes a control unit, adapted to provide the activation input to the control mechanism of the gastrointestinal capsule.
  • control unit is adapted to provide the activation input following ingestion of the gastrointestinal capsule by the subject. In other embodiments, the control unit is adapted to provide the activation input prior to ingestion of the gastrointestinal capsule by the subject.
  • control unit is adapted to provide to the control mechanism a current time of day, and the control mechanism is adapted to compute a delay time from the current time of day to the at least one predetermined time of day, and to activate the vibrating agitation mechanism following the delay time.
  • control unit further includes a timing device, and is adapted to provide to the capsule, as the activation input, an input signal indicating a current time of day being the at least one predetermined time of day, and the control mechanism adapted, upon receipt of the input signal, to activate the vibrating agitation mechanism to operate in the first vibrating mode of operation.
  • the current time of day is a time of day at an origin location of the subject. In other embodiments, the current time of day is a time of day at a destination location of the subject.
  • the activation input includes the at least one predetermined time of day.
  • the at least one predetermined time of day includes at least one default predetermined time of day. In some embodiments, the at least one predetermined time of day includes at least one time of day coinciding with at least one predetermined mealtime.
  • the at least one predetermined time of day includes at least one time of day coinciding with at least one predetermined mealtime in a time zone of the origin location of the subject.
  • the at least one predetermined time of day includes at least one time of day coinciding with at least one predetermined mealtime in a time zone of the destination location of the subject.
  • the at least one predetermined mealtime includes at least one default mealtime.
  • the at least one default mealtime includes a default breakfast time.
  • the default breakfast time is between 5am and 10am, between 6am and 10am, between 6am and 9am, between 6am and 8am, between 7am and 10am, between 7am and 9am, and between 7am and 8am.
  • the at least one default mealtime includes a default lunchtime.
  • the default lunchtime is between 12pm and 3pm, between 12pm and 2pm, or between 1pm and 3pm.
  • the at least one default mealtime includes a default suppertime.
  • the default suppertime is between 6pm and 10pm, between 7pm and 10pm, between 8pm and 10pm, between 6pm and 9pm, between 7pm and 9pm, or between 6pm and 8pm.
  • At least one of the capsule and the control unit includes an input mechanism for receiving subject-specific input from the subject, and wherein the at least one predetermined mealtime includes at least one subject-specific mealtime of the subject.
  • the subject-specific mealtime of the subject is a subject-specific mealtime in the time zone of the origin location of the subject. In other such embodiments, the subject-specific mealtime of the subject is a subject-specific mealtime in the time zone of the destination location of the subject.
  • At least one of the capsule and the control unit includes a location sensor adapted to identify a geographical region in which the capsule is located, and wherein the at least one predetermined time of day includes at least one region-specific time of day of the geographical region in which the capsule is located. In some such embodiments, the at least one region-specific time of day includes at least one region-specific mealtime of the geographical region in which the capsule is located.
  • the geographical region is a geographical region of the origin location of the subject. In other such embodiments, the geographical region is a geographical region of the destination location of the subject.
  • the activation input additionally includes a vibration protocol to be used by the vibrating agitation mechanism during the first vibrating mode of operation.
  • control mechanism is adapted to activate the agitation vibration mechanism to operate in the first vibrating mode of operation at the at least one predetermined time of day only if a minimum delay duration has passed between receipt of the activation input and the at least one predetermined time of day.
  • the vibrating agitation mechanism includes at least a radial agitation mechanism adapted, in the first vibrating mode of operation, to exert radial forces on the housing, in a radial direction with respect to the longitudinal axis of the housing, thereby to cause the vibrations exerted by the housing.
  • the radial agitation mechanism includes unbalanced weight attached to a shaft of an electric motor powered by the battery.
  • the vibrating agitation mechanism includes at least an axial agitation mechanism adapted, in the first vibrating mode of operation, to exert axial forces on the housing, in an axial direction with respect to the longitudinal axis of the housing, thereby to cause the vibrations exerted by the housing.
  • the axial agitation mechanism includes an electric motor powered by the battery and an urging mechanism, associated with, and driven by, the electric motor, the urging mechanism adapted to exert the axial forces.
  • the urging mechanism is adapted to exert the axial forces in opposite directions.
  • the urging mechanism is adapted to deliver at least a portion of the axial forces in a knocking mode.
  • the vibrating agitation mechanism is adapted in the first vibrating mode of operation, to exert radial forces on the housing in a radial direction with respect to the longitudinal axis of the housing and to exert axial forces on the housing in an axial direction with respect to the longitudinal axis of the housing, thereby to cause the vibrations exerted by the housing.
  • the vibrating agitation mechanism includes a radial agitation mechanism adapted to exert the radial forces and a separate axial agitation mechanism adapted to exert the axial forces.
  • the vibrating agitation mechanism includes a single agitation mechanism adapted to exert the radial forces and the axial forces.
  • the housing includes first and second members
  • the vibrating agitation mechanism is includes a mechanism adapted to effect a vibration by moving the first member of the housing in the opposite direction relative to the second member of the housing.
  • the vibrating mode of operation including a plurality of cycles, each of the cycles including a vibration duration followed by a repose duration, wherein the housing exerts the vibrations during the vibration duration.
  • the repose duration is greater than the vibration duration.
  • the vibration duration is in the range of 0.1 second to 10 seconds, 1 second to 10 seconds, 1 second to 9 seconds, 2 seconds to 9 seconds, 3 seconds to 9 seconds, 3 seconds to 8 seconds, 3 seconds to 7 seconds, 3 seconds to 6 seconds, 4 seconds to 6 seconds, or 5 seconds to 6 seconds.
  • the repose duration is in the range of 1 second to 180 seconds, 3 seconds to 180 seconds, 5 seconds to 180 seconds, 5 seconds to 150 seconds, 5 seconds to 120 seconds, 8 seconds to 100 seconds, 8 seconds to 30 seconds, 10 seconds to 80 seconds, 10 seconds to 70 seconds, 10 seconds to 60 seconds, 10 seconds to 50 seconds, 10 seconds to 40 seconds, 10 seconds to 30 seconds, 10 seconds to 20 seconds, or 15 seconds to 20 seconds.
  • a cumulative duration of the vibrating mode of operation is in the range of 1 hour to 12 hours, 2 hours to 10 hours, 2 hours to 8 hours, 2 hours to 6 hours, 2 hours to 4 hours, or 2 hours to 3 hours. In some embodiments, the cumulative duration is dependent on properties of the battery.
  • the vibrating agitation mechanism is configured such that a net force exerted by the housing on the environment is in the range of 50 grams-force to 600 grams-force.
  • the vibrating agitation mechanism is configured to exert the forces on the housing to attain a vibrational frequency within a range of 10Hz to 650Hz, 15Hz to 600Hz, 20Hz to 550Hz, 30Hz to 550Hz, 50Hz to 500Hz, 70Hz to 500Hz, 100Hz to 500Hz, 130Hz to 500Hz, or 150Hz to 500Hz.
  • the controlling of the vibrating agitation mechanism is effected so as to effect a mechanical stimulation of the wall of the gastrointestinal tract during the at least one predetermined time of day.
  • a method of treating the gastrointestinal tract of a subject including:
  • a method of treating the gastrointestinal tract of a subject including:
  • a method of treating the gastrointestinal tract of a subject including:
  • the method is adapted for treating an ailment of the gastrointestinal tract of the subject.
  • the subject is travelling from an origin location to a destination location, and the method is adapted for mitigating jetlag of the subject.
  • the first vibrating mode of operation occurs at the at least one predetermined time of day according to the time zone of the origin location.
  • the first vibrating mode of operation occurs at the at least one predetermined time of day according to the time zone of the destination location.
  • the first vibrating mode of operation occurs, at a first time of day of the at least one predetermined time of day according to the time zone of the origin location, and at a second time of day of the at least one predetermined time of day according to the time zone of the destination location.
  • the predetermined time of day is selected according to a circadian cycle of the subject.
  • the predetermined time of day is selected according to a gastric pH profile of the subject.
  • providing a gastrointestinal capsule includes providing the gastrointestinal capsule in an inoperative state, the method further including, at the capsule, receiving an activation input transitioning the capsule from the inoperative state to the operative state.
  • providing the gastrointestinal capsule includes providing the gastrointestinal capsule including at least one timing mechanism, and devoid of sensors for sensing an environment thereof.
  • receiving the at least one activation input includes receiving the at least one activation input from at least one sensor forming part of the gastrointestinal capsule.
  • the at least one sensor includes an illumination sensor
  • the receiving the at least one activation input includes receiving input indicating transition of the capsule from an illuminated environment to a dark environment.
  • the at least one sensor includes a pressure sensor
  • the receiving the at least one activation input includes receiving input indicating pressure applied to the capsule, which pressure is indicative of the capsule moving through a pharynx of the subject.
  • the at least one sensor includes a temperature sensor
  • the receiving the at least one activation input includes receiving input indicating transition of the capsule from an area with ambient temperature to an area with a human body temperature.
  • the at least one sensor includes an accelerometer
  • the receiving the at least one activation input includes receiving the activation input in response to a detected activation motion carried out with the gastrointestinal capsule.
  • the at least one sensor includes a moisture sensor
  • the receiving the at least one activation input includes receiving input indicating transition of the capsule from a dry environment to a humid environment.
  • the capsule further including a timing mechanism
  • the method further including, in response to the receiving the activation input, activating operation of the timing mechanism to track a time of day so as to identify the at least one predetermined time of day for activation of the vibration agitation mechanism.
  • receiving the activation input includes receiving the activation input from a control unit remote from the gastrointestinal capsule.
  • receiving the activation input includes receiving a current time of day
  • controlling the vibration agitation mechanism includes computing a delay time from the current time of day to the at least one predetermined time of day and activating the vibrating agitation mechanism to operate in the first vibration mode of operation following the delay time.
  • the activation input indicates that a current time of day is the at least one predetermined time of day, and wherein the controlling the vibration agitation mechanism to operate in the first vibration mode of operation occurs immediately following the receiving the activation input.
  • the current time of day is the current time of day in the origin location of the subject. In other embodiments, the current time of day is the current time of day in the destination location of the subject.
  • the at least one predetermined time of day includes at least one default predetermined time of day. In some embodiments, the at least one predetermined time of day includes at least one time of day coinciding with at least one predetermined mealtime.
  • the at least one predetermined mealtime includes at least one default mealtime.
  • the at least one default mealtime includes a default breakfast time.
  • the default breakfast time is between 5am and 10am, between 6am and 10am, between 6am and 9am, between 6am and 8am, between 7am and 10am, between 7am and 9am, and between 7am and 8am.
  • the at least one default mealtime includes a default lunchtime.
  • the default lunchtime is between 12pm and 3pm, between 12pm and 2pm, or between 1pm and 3pm.
  • the at least one default mealtime includes a default suppertime.
  • the default suppertime is between 6pm and 10pm, between 7pm and 10pm, between 8pm and 10pm, between 6pm and 9pm, between 7pm and 9pm, or between 6pm and 8pm.
  • the method further includes, prior to the controlling, receiving regional information relating to a geographical region in which the gastrointestinal capsule is located, and wherein the at least one predetermined time of day includes at least one region-specific time of day of the geographical region.
  • the at least one region-specific time of day comprises a region-specific mealtime of the geographical region.
  • the geographical region is a geographical region of the origin location of the subject. In other embodiments, the geographical region is a geographical region of the destination location of the subject.
  • receiving the regional information includes receiving an identification of the geographical region. In some embodiments, the identification of the geographical region is received from a location sensor. In some embodiments, receiving the regional information includes receiving the at least one region-specific time of day of the geographical region. In some embodiments, receiving the regional information includes receiving the at least one region-specific mealtime of the geographical region.
  • receiving regional information occurs in a control unit remote from the gastrointestinal capsule prior to the gastrointestinal capsule receiving the activation input, and wherein the receiving the activation input includes receiving activation input being on the received regional information.
  • receiving regional information is carried out by the control mechanism of the gastrointestinal capsule.
  • receiving the activation input additionally includes receiving a vibration protocol to be used by the control mechanism to control operation of the vibrating agitation mechanism.
  • the vibrating agitation mechanism includes at least a radial agitation mechanism
  • the controlling includes controlling the radial agitation mechanism, in the first vibrating mode of operation, to exert radial forces on the housing, in a radial direction with respect to the longitudinal axis of the housing, thereby to cause the vibrations exerted by the housing.
  • the controlling includes controlling the vibrating agitation mechanism, in the first vibrating mode of operation, to exert radial forces on the housing in a radial direction with respect to the longitudinal axis of the housing and to exert axial forces on the housing in an axial direction with respect to the longitudinal axis of the housing, thereby to cause the vibrations exerted by the housing.
  • the vibrating agitation mechanism includes a radial agitation mechanism adapted to exert the radial forces and a separate axial agitation mechanism adapted to exert the axial forces.
  • the housing includes first and second members, and wherein the controlling the vibrating agitation mechanism includes effecting a vibration by moving the first member of the housing in the opposite direction relative to the second member of the housing.
  • the repose duration is greater than the vibration duration.
  • the repose duration is in the range of 1 second to 180 seconds, 3 seconds to 180 seconds, 5 seconds to 180 seconds, 5 seconds to 150 seconds, 5 seconds to 120 seconds, 8 seconds to 100 seconds, 8 seconds to 30 seconds, 10 seconds to 80 seconds, 10 seconds to 70 seconds, 10 seconds to 60 seconds, 10 seconds to 50 seconds, 10 seconds to 40 seconds, 10 seconds to 30 seconds, 10 seconds to 20 seconds, or 15 seconds to 20 seconds.
  • a duration of each of the plurality of cycles is in the range of 1.1 seconds to 200 seconds, 5 seconds to 200 seconds, 10 seconds to 200 seconds, 10 seconds to 150 seconds, 10 seconds to 100 seconds, 10 seconds to 80 seconds, 10 seconds to 50 seconds, 10 seconds to 40 seconds, 10 seconds to 30 seconds, 15 seconds to 50 seconds, 15 seconds to 40 seconds, 15 seconds to 30 seconds, or 15 seconds to 25 seconds.
  • controlling the vibrating agitation mechanism includes controlling the vibrating agitation mechanism such that a cumulative duration of the vibrating mode of operation is in the range of 1 hour to 12 hours, 2 hours to 10 hours, 2 hours to 8 hours, 2 hours to 6 hours, 2 hours to 4 hours, or 2 hours to 3 hours. In some embodiments, the cumulative duration is dependent on properties of the battery.
  • the vibrating agitation mechanism in the first vibration mode of operation, is configured such that a net force exerted by the housing on the environment is in the range of 50 grams-force to 600 grams-force.
  • controlling of the vibrating agitation mechanism includes controlling the vibrating agitation mechanism so as to effect a mechanical stimulation of the wall of the gastrointestinal tract during the at least one predetermined time of day.
  • inventive gastrointestinal treatment system and method of treating the gastrointestinal tract using the inventive gastrointestinal treatment system, may be better understood with reference to the drawings and the accompanying description.
  • vibrating ingestible capsule relates to an ingestible capsule adapted to at least intermittently vibrate, for a cumulative duration of at least one minute, in accordance with a vibration protocol of the capsule.
  • vibration agitation mechanism refers to a any type of mechanism that vibrates or causes elements in its vicinity to vibrate, including a vibration motor or engine.
  • the term “intermittently activated vibrating agitation mechanism” refers to a vibration engine that vibrates and is operative at certain times, and does not vibrate at other times, the activation times being selected by a control mechanism or other control unit controlling the vibration engine.
  • vibration protocol relates to a protocol specifying vibration parameters of an intermittently activated vibrating agitation mechanism of a vibrating ingestible capsule.
  • the vibration protocol relates to an activation delay for initiating vibration (a duration between activation of the capsule and the first activation of the vibration engine), a vibration rate (number of vibration cycles per hour), a vibration duration and a repose duration for each vibration cycle, a vibration frequency, an amount of force exerted by the vibrations, and the like.
  • the term "treatment procedure” relates to parameters of a treatment utilizing vibrating ingestible capsules, which are typically defined by a treating physician or medical practitioner.
  • the treatment procedure may include the number of capsules to be taken within a specific time duration (e.g. 3 capsules per week, 2 capsules per day), the frequency at which capsules should be taken, the time of day at which capsules should be taken, whether the capsule should be taken with or without food, and the like.
  • treatment protocol relates to all aspects of treatment of a subject with a vibrating ingestible capsule, and includes the treatment procedure as well as the vibration protocol to be used for treating the subject.
  • activation input relates to an input received by a control mechanism or control mechanism of a vibrating ingestible capsule, which causes the control mechanism or control mechanism of the capsule to activate itself, so as to be able to process inputs and/or to control additional components of the capsule.
  • the activation input may be received from an element forming part of the capsule, such as a sensor sensing specific conditions in which the capsule should be activated, or from a remote source, such as a remote control mechanism, for example by way of a signal transmitted to the capsule, magnetic field applied to the capsule, specific motion applied to the capsule, or any other type of input provided to the capsule from a remote source.
  • a vibrating ingestible capsule is said to be in an "inoperative state" when the capsule is in a storage condition, intended to preserve the life of a battery thereof.
  • components of the capsule which are intended to receive or to provide an activation input such as specific sensors, transceivers, and/or timing mechanisms may be active at least to a minimal degree.
  • a control mechanism controlling vibration of the capsule is inactive.
  • a vibrating ingestible capsule is said to be in an "operative state" when the control mechanism of the capsule is processing inputs and data, and can cause a vibrating agitation mechanism of the capsule to vibrate.
  • jetlag relates to any symptom resulting from a change in time zones, including, but not limited to, a shift in a person's sleep schedule, acute constipation resulting from travel, and the like.
  • the term "mitigating jetlag” relates to appreciably decreasing any jetlag symptom, for example by at least 25%. For example, for a traveler who typically suffers from acute constipation for the first 48 hours of travel, jetlag would be mitigated if the traveler suffered from such acute constipation for, at most, the first 36 hours of travel.
  • chronic constipation relates to a spontaneous bowel movement (SBM) frequency of at most 3 SBMs per week
  • acute constipation relates to a subject suffering from a specific event of constipation, without necessarily suffering from chronic constipation.
  • the subject may be constipated for several days following travel, or during travel, for example as part of the subject's jetlag symptoms.
  • Figure 1 is a schematic block diagram of a gastrointestinal treatment system 100 including a vibrating ingestible capsule 101 according to an embodiment of the present invention.
  • gastrointestinal treatment system 100 includes vibrating ingestible capsule 101.
  • Capsule 101 includes a capsule housing or shell 102, arranged along a longitudinal axis and having disposed therein a vibrating agitation mechanism 104.
  • a control mechanism 106 which may for example be, or include, a processor, is adapted to control operation of the vibrating agitation mechanism 104, and at least one power source 108 provides power to vibrating agitation mechanism 104 and control mechanism 106.
  • Power source 108 may be any suitable power source, such as one or more alkaline or silver oxide batteries, primary batteries, rechargeable batteries, capacitors and/or supercapacitors.
  • control mechanism 106 is adapted, in response to receipt of an activation input or when the capsule is in an operative state, to activate vibrating agitation mechanism 104 to operate in the vibrating mode of operation at at least one predetermined time of day, as described in detail hereinbelow with respect to Figure 2 .
  • the capsule is in an inoperative state, until the receipt of an activation input, which causes control mechanism 106 to transition the capsule from the inoperative state to an operative state.
  • control mechanism 106 is functionally associated with, or includes, a timing mechanism 110, powered by power source 108 and adapted to track at least one time characteristic, such as the time of day, a duration that has passed since an activation input was received, or a duration that has passed since the subject ingested capsule 101.
  • a timing mechanism 110 powered by power source 108 and adapted to track at least one time characteristic, such as the time of day, a duration that has passed since an activation input was received, or a duration that has passed since the subject ingested capsule 101.
  • control mechanism 106 in response to receipt of an activation input, is adapted to activate operation of timing mechanism 110 to track a time of day, so as to identify the at least one predetermined time of day for activation of vibration agitation mechanism 104.
  • capsule 101 is devoid of any sensors for sensing an environment thereof.
  • control mechanism 106 is adapted, in response to receipt of an activation input, to wait a predetermined delay time, and following the predetermined delay time, at a time coinciding with the at least one predetermined time of day, to activate vibrating agitation mechanism 104 to operate in the first vibration mode of operation.
  • capsule 101 further includes at least one sensor 112, functionally associated with control mechanism 106.
  • the at least one sensor 112 may be adapted to sense at least one parameter within capsule 101 or in an environment of capsule 101, and may include a temperature sensor, an illumination sensor, a moisture sensor, a pressure sensor, an accelerometer, or any other suitable sensor.
  • the at least one sensor 112 is adapted to identify a specific condition in capsule 101 or in the vicinity thereof, and to provide an activation input to control mechanism 106 in response to identification of the condition.
  • the condition is indicative of the subject ingesting capsule 101.
  • sensor 112 may include an illumination sensor, adapted to identify transition of capsule 101 from an illuminated environment (e.g. outside the human body) to a dark environment (e.g. within the human body) and to provide an activation input in response to identification of such a transition.
  • an illumination sensor adapted to identify transition of capsule 101 from an illuminated environment (e.g. outside the human body) to a dark environment (e.g. within the human body) and to provide an activation input in response to identification of such a transition.
  • sensor 112 may include a pressure sensor adapted identify pressure applied to the capsule 101, which pressure is indicative of the capsule moving through a pharynx of the subject, and to provide an activation input in response to identification of such pressure.
  • sensor 112 may include a temperature sensor adapted to identify transition of capsule 101 from an area with ambient temperature (e.g. outside the human body) to an area with a human body temperature and to provide an activation input in response to identification of such a transition.
  • ambient temperature e.g. outside the human body
  • sensor 112 may include a motion or acceleration sensor, such as an accelerometer, adapted to identify an activation motion carried out by a user on capsule 101 and to provide an activation input in response to identification of such a transition.
  • a motion or acceleration sensor such as an accelerometer
  • An example of an accelerometer providing an activation input for a gastrointestinal capsule is provided in US Patent Application No. 15/169,065 Filed on May 29, 2016 .
  • capsule 101 further includes a location sensor 114, such as a GPS or GLONASS receiver, functionally associated with control mechanism 106.
  • Location sensor 114 may be adapted to identify the geographic location of the capsule.
  • control unit 120 may further include a location sensor 124, such as a GPS or GLONASS receiver, adapted to identify the geographic location of the control unit.
  • a location sensor 124 such as a GPS or GLONASS receiver
  • control unit 120 may further include a timing mechanism 126, adapted to track at least one time characteristic, such as the time of day, or a duration that has passed since a control instruction was provided to capsule 101.
  • a timing mechanism 126 adapted to track at least one time characteristic, such as the time of day, or a duration that has passed since a control instruction was provided to capsule 101.
  • control unit 120 may further include a user input receiver 128, such as a keyboard, touch screen, or touch pad, adapted to receive input from a user, such as the subject, a medical professional treating the subject, or a caregiver of the subject.
  • a user input receiver 128, such as a keyboard, touch screen, or touch pad adapted to receive input from a user, such as the subject, a medical professional treating the subject, or a caregiver of the subject.
  • Control unit 120 may be any suitable type of control unit.
  • control unit may be a suitably configured smart phone or a tablet computer.
  • control unit 120 may provide inputs to capsule 101 by remotely transmitting the inputs from input providing mechanism 122 to remote input receiving mechanism 116, for example using a short range wireless communication method, such as radio frequency (RF) communication or Bluetooth ® communication.
  • RF radio frequency
  • control unit 120 is adapted to provide the activation input to control mechanism 106 of capsule 101. In some such embodiments, control unit 120 provides the activation input prior to the subject ingesting capsule 101, whereas in other embodiments control unit 120 provides the activation input following ingestion of capsule 101 by the subject.
  • control mechanism 106 of capsule 101 is pre-programmed with the predetermined time of day, which may be, for example, a default time of day.
  • capsule 101 is adapted to be used to mitigate jetlag of a user travelling from an origin location having an origin time zone to a destination location having a destination time zone.
  • the pre-determined time of day is a time of day in the origin time zone.
  • the pre-determined time of day is a time of day in the destination time zone.
  • the predetermined time of day is a time of day in a home time zone, which is the time zone at which the subject normally resides, or has been residing for at least a predetermined duration, for example at least one week.
  • timing mechanism 110 provides control mechanism 106 with the current time of day, such that, following receipt of the activation input, or once capsule 101 is in the operative state, control mechanism tracks the current time of day, for example in the origin time zone, the destination time zone, or the home time zone, until arrival of the predetermined time, and then activates vibrating agitation mechanism according to a suitable vibration protocol.
  • the predetermined time of day is provided to control mechanism 106 as part of the activation input, or in another input, for example provided by control unit 120.
  • the activation input (or another input) provided to control mechanism 106, for example by control unit 120, includes the current time of day at the time of providing the activation input, for example in the origin time zone, the destination time zone, or the home time zone.
  • control mechanism 106 and/or timing mechanism 110 is adapted to compute a delay time from the received current time of day (e.g. the time of the activation input) to the predetermined time of day, to wait the computed delay time and subsequently to activate vibrating agitation mechanism 104 according to a suitable vibration protocol.
  • control mechanism 106 is not provided with the predetermined time of day. Instead, at the predetermined time of day, as indicated by timing mechanism 126, control unit 120 provides an input to control mechanism 106 indicating that the current time of day is the predetermined time, and that the vibrating agitation mechanism should be activated. Control mechanism 106 is adapted to activate vibrating agitation mechanism 104 to operate in the vibrating mode of operation immediately responsive to receipt of such an input.
  • the predetermined mealtime is a default mealtime.
  • the default mealtime may be a default breakfast time, which may be between 5am and 10am, between 6am and 10am, between 6am and 9am, between 6am and 8am, between 7am and 10am, between 7am and 9am, and between 7am and 8am.
  • the default mealtime may be a default lunch time, which may be between 12pm and 3pm, between 12pm and 2pm, or between 1pm and 3pm.
  • the default meal time may be a default supper time, which may be between 6pm and 10pm, between 7pm and 10pm, between 8pm and 10pm, between 6pm and 9pm, between 7pm and 9pm, or between 6pm and 8pm.
  • the predetermined time of day is a user-specific time of day, or a user-specific mealtime at which the subject typically eats his/her meals.
  • user input receiver 128 of control unit 120 (or an input receiver forming part of capsule 101 (not shown)), is adapted to receive, from the user (e.g. the subject or a caregiver of the subject) information about the user-specific time of day or user-specific mealtime.
  • Control unit 120 may then provide the user-specific time of day or the user-specific mealtime to control mechanism 106, for example as part of an activation input or as a separate input.
  • the predetermined time of day is suited to the geographic region in which the capsule, the control unit 120, or the subject, are located. For example, if the subject has ingested the capsule, and has changed time zones since ingesting the capsule (for example flew from New-York to Chicago), the predetermined time of day may be adjusted to correspond to the new time zone in which the user is located.
  • the predetermined time of day is a region-specific mealtime at which the people in a geographical region at which the subject (or capsule) is located typically eat their meals.
  • the times at which people typically have supper, or dinner, may vary greatly between different geographical regions. For example, in the U.S. typical supper times are between 5pm and 8pm or between 6pm and 8pm, whereas in Argentina most people only eat their supper between 9pm and 11pm, or even as late as midnight. Thus, the geographical region in which the capsule (and the subject) is located, may be used to identify the typical mealtimes of the subject.
  • location sensor 114 of capsule 101 may identify the location of the capsule, and provide the location or a region of the location to control mechanism 106.
  • location sensor 124 of control unit 120 may identify the location of the control unit, and may provide the location or a region of the location to control mechanism 106 as part of the activation input or as part of another input.
  • Control mechanism 106 may then determine the predetermined time of day, or region-specific mealtime, at which the vibrating agitation mechanism 104 should be in the operative mode of operation, based on the region.
  • control mechanism 106 may be preprogrammed with predetermined times of day for specific regions, and may select a suitable pre-programmed predetermined time of day based on the identified region.
  • control mechanism 106 may access a database (not shown) to find the region-specific time of day, or region-specific mealtimes, for the identified region.
  • location sensor 124 of control unit 120 may identify the location of the control unit, and may obtain, based on the identified location, the region-specific predetermined time(s) of day or region-specific mealtime(s), for example by accessing a pre-programmed list or by accessing a database (not shown). Control unit 120 may then provide the obtained region-specific predetermined time(s) of day to control mechanism 106, substantially as described hereinabove.
  • the predetermined time of day is suited to the geographic region from which the capsule, the control unit 120, or the subject, originate, or to the origin time zone of the subject. For example, if the subject has ingested the capsule, and has changed time zones since ingesting the capsule (for example flew from New-York to Chicago), the predetermined time of day is preferably maintained at the origin time zone of the origin location of the subject.
  • the predetermined time of day is suited to the geographic region at which the capsule, the control unit 120, or the subject, arrive, or to the destination time zone of the subject. For example, if the subject has ingested the capsule, and has changed time zones since ingesting the capsule (for example flew from New-York to Chicago), the predetermined time of day is preferably maintained at the destination time zone at which the subject has arrived.
  • the predetermined time of day is suited to the circadian cycle of the user, or to a default circadian cycle.
  • the predetermined time of day may be one occurring near a time that, according to the circadian cycle, the user is likely to have a bowel movement, such that operation of the capsule 101 may "assist" the gastrointestinal tract in generating, or completing, such a bowel movement. Additional examples relating to the circadian cycle are described hereinbelow with respect to Figure 3 .
  • the predetermined time of day may be selected to be a time of day at which the gastric pH of the user is relatively high, as explained in further detail hereinbelow with respect to Figure 4 .
  • control mechanism 106 only activates vibrating agitation mechanism in the vibrating mode of operation at the predetermined time, if some minimum threshold duration has passed since capsule 101 was activated to be in the operative state, since receipt of the activation input, or since the user ingested the capsule.
  • the capsule may be pre-programmed such that control mechanism 106 is adapted to activate vibrating agitation mechanism in the vibrating mode of operation from 6am to 8am, and from 6pm to 8pm, and the minimum threshold duration is four hours from ingestion of the capsule.
  • the vibrating agitation mechanism may be any suitable mechanism that can be intermittently activated and can apply suitable forces onto capsule housing 102.
  • intermittently activated vibrating agitation mechanism 104 may include a radial agitation mechanism adapted to exert radial forces on capsule housing 102, in a radial direction with respect to the longitudinal axis of housing 102.
  • the radial agitation mechanism may include an unbalanced weight attached to a shaft of an electric motor powered by said battery, substantially as described in US Patent Number 9,701,150 .
  • intermittently activated vibrating agitation mechanism 104 may include an axial agitation mechanism adapted to exert radial forces on the capsule housing 102, in an axial direction with respect to a longitudinal axis of housing 102.
  • the axial agitation mechanism may include an electric motor powered by the battery and an urging mechanism, associated with, and driven by, the electric motor, such that the urging mechanism adapted to exert said axial forces, substantially as described in US Patent Number 9,707,150 .
  • the urging mechanism adapted to exert the axial forces in opposite directions.
  • the urging mechanism is adapted to deliver at least a portion of the axial forces in a knocking mode.
  • the forces exerted by intermittently activated vibrating agitation mechanism 104 on capsule housing 102 in the vibration mode of operation include radial forces in a radial direction with respect to the longitudinal axis of the housing and axial forces in an axial direction with respect to the longitudinal axis.
  • a single agitation mechanism exerts both the radial and the axial forces.
  • the axial forces are exerted by one agitation mechanism, and the radial forces are exerted by another, separate, agitation mechanism, where both agitation mechanisms form part of intermittently activated vibrating agitation mechanism 104.
  • the intermittently activated vibrating agitation mechanism 104 may include a magnet mounted onto a rotor adapted to exert a magnetic field as well as radial forces on capsule housing 102.
  • a magnetic vibration agitation mechanism is described in US Patent Application Number 15/058,216 filed on March 2, 2016 and entitled "PHYSIOTHERAPY DEVICE AND METHOD FOR CONTROLLING THE PHYSIOTHERAPY DEVICE".
  • intermittently activated vibrating agitation mechanism 104 is adapted to have a plurality of vibration cycles, where each cycle includes a vibration duration followed by a repose duration. Forces are exerted by the vibrating agitation mechanism 104 on capsule housing 102 only during the vibration duration, and as such capsule housing 102 only exerts forces on an environment thereof during the vibration duration.
  • the number of vibration cycles per hour is in the range of 20 to 400, 40 to 400, 60 to 400, 80 to 400, 40 to 380, 60 to 380, 80 to 380, 40 to 360, 60 to 360, 100 to 330, 100 to 300, 100 to 280, 100 to 250, 100 to 220, 100 to 200, 120 to 300, 120 to 280, 120 to 250, 120 to 220, 120 to 200, 150 to 300, 150 to 280, 150 to 250, 150 to 220, 150 to 200, 170 to 300, 170 to 250, 170 to 220, or 170 to 200.
  • the repose duration is greater than the vibration duration.
  • the vibration duration is in the range of 0.1 second to 10 seconds, 1 second to 10 seconds, 1 second to 9 seconds, 2 seconds to 9 seconds, 3 seconds to 9 seconds, 3 seconds to 8 seconds, 3 seconds to 7 seconds, 3 seconds to 6 seconds, or 4 seconds to 6 seconds.
  • the repose duration is in the range of 1 second to 180 seconds, 3 seconds to 180 seconds, 5 seconds to 180 seconds, 5 seconds to 150 seconds, 5 seconds to 120 seconds, 8 seconds to 100 seconds, 8 seconds to 30 seconds, 10 seconds to 80 seconds, 10 seconds to 70 seconds, 10 seconds to 60 seconds, 10 seconds to 50 seconds, 10 seconds to 40 seconds, 10 seconds to 30 seconds, 10 seconds to 20 seconds, or 15 seconds to 20 seconds.
  • the total duration of one vibration cycle is in the range of 1.1 seconds to 200 seconds, 5 seconds to 200 seconds, 10 seconds to 200 seconds, 10 seconds to 150 seconds, 10 seconds to 100 seconds, 10 seconds to 80 seconds, 10 seconds to 50 seconds, 10 seconds to 40 seconds, 10 seconds to 30 seconds, 15 seconds to 50 seconds, 15 seconds to 40 seconds, 15 seconds to 30 seconds, or 15 seconds to 25 seconds.
  • the cumulative duration of the vibrating mode of operation is in the range of 1 hour to 12 hours, 2 hours to 10 hours, 2 hours to 8 hours, 2 hours to 6 hours, 2 hours to 4 hours, or 2 hours to 3 hours. It will be appreciated that the cumulative duration of vibration cycles may be dependent on properties of power source 108.
  • the vibration mode of operation may be intermittent, or interrupted, such that vibrating agitation mechanism 104 is operative in the vibration mode for a first duration, for example 30 minutes, then does have any vibration cycles for a second duration, for example 1 hour, and then is operative in the vibration mode and has vibration cycles for a third duration, for example two hours.
  • the cumulative duration relates to the sum of all durations during which vibrating agitation mechanism 104 was operative in the vibration mode and included vibration cycles, including the vibration duration and the repose duration of the vibration cycle.
  • vibrating agitation mechanism 104 is configured to exert said forces on capsule housing 102 to attain a capsule housing 102 vibrational frequency within a range of 10Hz to 650Hz, 15Hz to 600Hz, 20Hz to 550Hz, 30Hz to 550Hz, 50Hz to 500Hz, 70Hz to 500Hz, 100Hz to 500Hz, 130Hz to 500Hz, or 150Hz to 500Hz.
  • a specific capsule may be controlled by the control mechanism such that different vibrational frequencies may be attained and/or different net forces may be exerted, by the capsule in different vibration cycles of the capsule. Due to the natural distinction between subjects, use of multiple different parameters in different vibration cycles of a single capsule would allow the capsule to successfully treat multiple subjects, even if the personal optimal treatment for those subjects is not the same, as there is a higher chance that in at least some of the vibration cycles the activation parameters of the capsule would reach, or be close to, the optimal parameters for each specific subject.
  • control mechanism 106 is adapted to receive information relating to the desired vibration protocol from control unit 120, prior to ingestion of the capsule or to activation thereof, or during the capsule's traversal of the subject's GI tract.
  • the information may be remotely transmitted from control unit 120 to control mechanism 106, for example using a short range wireless communication method.
  • the information is transmitted as a list of vibration parameters for effecting the vibration protocol.
  • the information is transmitted as executable code for effecting the first vibration protocol.
  • the information includes one or more of a predetermined time of day, a region in which the control unit is located, a desired number of vibration cycles, a desired vibration duration in each vibration cycle, a desired repose duration in each vibration cycle, a desired cumulative vibration duration, and the like.
  • control mechanism 106 is adapted to control vibrating agitation mechanism 104 so that the capsule applies forces to an environment thereof to effect a mechanical stimulation of the wall of the gastrointestinal tract of the subject at the predetermined time(s).
  • the method described herein may be used for mitigating at least an acute constipation symptom of jetlag of a subject.
  • the treatment protocol may be selected at least partially according to a travel plan of the subject.
  • the treatment protocol may take into consideration, for example, times the subject will be in travelling (e.g. on an airplane, boat, or train), the origin time zone (from which the subject will be leaving), the destination time zone (at which the subject will be arriving), and the time of day at which the subject will be arriving at the destination.
  • a control mechanism 106 of an ingestible capsule 101 is provided with a predetermined time (or times) of day at which the vibrating agitation mechanism should be operated in the vibrating mode of operation.
  • the control mechanism may also be provided with a specification of a time zone to which the predetermined time(s) of day should relate, for example an origin time zone or a destination time zone of a travelling subject.
  • control mechanism 106 may optionally receive, or be programmed with, a desired vibration protocol for the subject.
  • the capsule may be activated for use, by transitioning the capsule from an inoperative state to an operative state, for example by receipt of an activation input.
  • control mechanism 106 control vibrating agitation mechanism 104 such that the vibrating mode of operation occurs at the predetermined time(s) of day.
  • providing of the predetermined time(s) at step 202 and/or providing the desired vibration protocol for the subject at step 204 may be effected by a control unit, such as control unit 120 of Figure 1 .
  • control unit 120 may provide to control mechanism 106 the predetermined time of day, a user-specific predetermined time of day, a region-specific predetermined time of day, or a time-zone specific time of day as described hereinabove.
  • step 202 may be carried out at any time prior to operating to the vibrating agitation mechanism in the vibrating mode of operation at step 210, and specifically may be carried out prior to ingestion of the capsule by the subject, or following the subject ingesting the capsule.
  • the programming of the vibration protocol and/or of the predetermined time of day may include remotely transmitting the desired vibration protocol and/or predetermined time of day from the control unit 120 to the control mechanism 106, for example using a short range wireless communication method.
  • the desired vibration protocol is transmitted as a list of vibration parameters for effecting the vibration protocol.
  • the desired vibration protocol is transmitted as executable code for effecting the vibration protocol.
  • control unit provides the predetermined time of day to control mechanism 106 at the predetermined time of day, which is equivalent to giving the command "operate the vibrating agitation mechanism 104 now".
  • step 202 is carried out following the subject ingesting the capsule at step 208.
  • the capsule is activated for use at step 206.
  • the capsule is activated by receipt of an activation input.
  • the activation input may be received from the control unit 120 or from sensors within the capsule sensing that the capsule has been ingested or that a user has carried out an activation motion with the capsule.
  • the capsule is activated prior to the user ingesting the capsule at step 208, for example by a signal from the control unit or by the user carrying out an activation motion.
  • the activation input is provided at the time of ingestion or immediately thereafter, for example by sensors sensing a change in the environment of the capsule due to its ingestion, as described at length hereinabove.
  • the activation input may be provided remotely when the capsule is already in the body of the subject, for example by remote communication from control module 120.
  • capsule 101 Following activation of capsule 101, or together therewith, capsule 101 is ingested by the subject, and begins to travel through the gastrointestinal tract of the subject, as seen at step 208.
  • Operation of vibrating agitation mechanism 104 in the vibrating mode of operation at step 210 effects vibration of capsule housing 102, as described hereinabove, such that the housing exerts vibrations on the environment surrounding the capsule.
  • vibration of capsule housing 102 may be intended to effect a mechanical stimulation of the wall of the gastrointestinal tract at the predetermined time of day.
  • a treatment session as defined in steps 202 to 210 may be repeatedly administered to the subject as specified in the treatment protocol for the subject, determined or obtained at step 200.
  • the treatment protocol includes administering a plurality of treatment sessions to the subject.
  • the treatment protocol includes administering at least one treatment session to the subject per week, over a treatment period of at least two weeks, at least at least three weeks, at least four weeks, at least five weeks, at least six weeks, or at least eight weeks.
  • the treatment protocol includes administering 1 to 7 treatment sessions per week, 3 to 14 treatment sessions per two weeks, 2 to 7 treatment sessions per week, 5 to 14 treatment sessions per two weeks, 3 to 7 treatment sessions per week, 7 to 14 treatment sessions per two weeks, 4 to 7 treatment sessions per week, or 5 to 7 treatment sessions per week.
  • FIG. 3 is a schematic illustration of the circadian cycle of a person, including suitable times of day for the implementation of the method of Figure 2 .
  • the times of day shown in Figure 3 and the corresponding body activities or characteristics at those times of day, are known in the art, and have been shown in medical and scientific research.
  • Figure 4 is a graphic illustration of the gastric pH of a person, indicating suitable times of day for the implementation of the method of Figure 2 .
  • gastric pH of a typical person oscillates during the day, and is relatively high at typical mealtimes, and then decreases gradually until the next mealtime.
  • gastric pH is sensed by mechanoreceptors in the GI tract, and is tied to peristalsis in the GI tract (see for example " Acid sensing in the gastrointestinal tract" to Holtzer, (Am J Physiol Gastrointest Liver Physiol. 2007 Mar; 292(3): G699-G705., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4370835/ ) in the section about Esophago-gastro-duodenal motility).
  • tissue subjects Half of the participating subjects, termed herein “trial subjects”, were treated with a vibrating gastrointestinal capsule according to a treatment protocol, in accordance with the present invention, while the other half, termed herein “sham subjects”, were treated with a sham capsule, which appeared and behaved identically to the vibrating gastrointestinal capsule prior to ingesting thereof, but did not vibrate within the subject's alimentary tract.
  • the treatment protocol included treatment cycles including administering one gastrointestinal capsule per day five times per week, repeated for a treatment duration of six weeks.
  • the administered capsules included a non-chargeable battery as the power source, and a coin-type eccentric vibration motor as the vibrating agitation mechanism.
  • the capsules administered to the "trial subjects" were programmed to have operate in the vibration mode of operation during the morning hours following an activation time delay of at least 8 hours, and when in the vibration mode of operation, to have vibration treatment cycles including a 3 second vibration duration followed by a 16 second repose duration, for a cumulative treatment duration of 1.5 to 3 hours.
  • the force applied by the capsule housing on the surrounding environment was in the range of 200gram-force to 500gram-force, and the vibrational frequency was in the range of 120Hz to 280Hz. Different specific forces were applied to the surrounding environment, and corresponding different vibrational frequencies were attained, in different vibration cycles of the administered capsules.
  • a study which included 26 participating subjects suffering from constipation was conducted. 16 of the participating subjects, termed herein “trial subjects”, were treated with a vibrating gastrointestinal capsule according to a treatment protocol, in two different arms of the study, in accordance with the present invention, while the remaining ten subjects, termed herein “sham subjects”, were treated with a sham capsule, which appeared and behaved identically to the vibrating gastrointestinal capsule prior to ingesting thereof, but did not vibrate within the subject's alimentary tract.
  • the results illustrated in Figure 5B indicate that improvement of the subject's symptoms of the subject's symptoms by addition of CSBMs is coincidental with times at which the capsule vibrates, thus demonstrating the efficacy of the capsules, and the benefit in activating the capsules to operate at specific times of day, which coincide with mealtimes and/or at which the circadian cycle indicates that a bowel movement is likely and prior to bowel movements becoming unlikely according to the circadian cycle.

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Claims (11)

  1. Gastrointestinales Behandlungssystem, das eine gastrointestinale Kapsel (101) beinhaltet, die ausgelegt ist, um einen gastrointestinalen Trakt eines Subjekts nach Einnahme der gastrointestinalen Kapsel zur Behandlung von Verstopfung zu behandeln, wobei die gastrointestinale Kapsel Folgendes umfasst:
    (a) ein Gehäuse (102), das eine Längsachse aufweist;
    (b) einen vibrierenden Agitationsmechanismus (104), wobei der vibrierende Agitationsmechanismus ausgelegt ist, sodass in einem ersten vibrierenden Betriebsmodus das Gehäuse Vibrationen auf eine Umgebung ausübt, welche die gastrointestinale Kapsel umgibt; und
    (c) eine Antriebsversorgung (108), die innerhalb des Gehäuses angeordnet und ausgelegt ist, um den vibrierenden Agitationsmechanismus anzutreiben; gekennzeichnet durch
    (d) einen programmierbaren Steuermechanismus (106), der ausgelegt ist, um als Reaktion auf Empfang einer Aktivierungseingabe programmiert zu werden, um eine Verzögerungszeit von der Zeit des Empfangs der Aktivierungseingabe zu zumindest einer vorbestimmten Tageszeit zu berechnen, um die berechnete Verzögerungszeit zu warten und um anschließend den vibrierenden Agitationsmechanismus zu aktivieren, um in dem ersten vibrierenden Betriebsmodus zu der zumindest einen vorbestimmten Tageszeit zu arbeiten, und
    (e) einen Zeitplanungsmechanismus, der Teil des programmierbaren Steuermechanismus bildet oder funktionell damit assoziiert ist, wobei der Zeitplanungsmechanismus ausgelegt ist, um zumindest eine Zeiteigenschaft zu verfolgen, wobei die zumindest eine Zeiteigenschaft zumindest eines von der Tageszeit, einer Dauer, die verstrichen ist, seit die Aktivierungseingabe empfangen wurde, und einer Dauer, die verstrichen ist, seit das Subjekt die gastrointestinale Kapsel eingenommen hat, beinhaltet.
  2. Gastrointestinales Behandlungssystem nach Anspruch 1, wobei der programmierbare Steuermechanismus (106) ausgelegt ist, um programmiert zu sein, sodass die Zeit, zu welcher der vibrierende Agitationsmechanismus in dem ersten vibrierenden Betriebsmodus arbeitet, zumindest eine vorbestimmte Tageszeit gemäß zumindest einem von einer Zeitzone eines Ursprungsortes, von dem das Subjekt reist, und einer Zeitzone eines Zielortes, zu dem das Subjekt reist, ist.
  3. Gastrointestinales Behandlungssystem nach Anspruch 2, wobei die zumindest eine vorbestimmte Tageszeit eine erste vorbestimmte Tageszeit und eine zweite vorbestimmte Tageszeit, die sich von der ersten vorbestimmten Tageszeit unterscheidet, beinhaltet,
    wobei der programmierbare Steuermechanismus (106) ausgelegt ist, um programmiert zu sein, sodass eine Zeit, zu welcher der vibrierende Agitationsmechanismus in dem ersten vibrierenden Betriebsmodus arbeitet, die erste vorbestimmte Tageszeit gemäß einer Zeitzone des Ursprungsortes ist und die zweite vorbestimmte Tageszeit gemäß einer Zeitzone des Zielortes ist.
  4. Gastrointestinales Behandlungssystem nach einem der Ansprüche 1 bis 3, wobei die Kapsel frei von Sensoren zum Erfassen einer Umgebung davon ist.
  5. Gastrointestinales Behandlungssystem nach einem der Ansprüche 1 bis 4, ferner umfassend eine Steuereinheit (120), die ausgelegt ist, um dem programmierbaren Steuermechanismus (106) eine aktuelle Tageszeit bereitzustellen; und
    wobei der programmierbare Steuermechanismus ausgelegt ist, um die Verzögerungszeit von der aktuellen Tageszeit zu der zumindest einen vorbestimmten Tageszeit zu berechnen.
  6. Gastrointestinales Behandlungssystem nach Anspruch 5, wobei die Steuereinheit (120) ausgelegt ist, um der Kapsel (101) als die aktuelle Tageszeit eine Tageszeit an einem von einem Ursprungsort des Subjekts und einem Zielort des Subjekts bereitzustellen.
  7. Gastrointestinales Behandlungssystem nach Anspruch 5 oder Anspruch 6, wobei zumindest eines von der Kapsel (101) und der Steuereinheit (120) einen Benutzereingabeempfänger (128) zum Empfangen von subjektspezifischer Eingabe von einem Subjekt beinhaltet, und wobei die zumindest eine vorbestimmte Tageszeit zumindest eine subjektspezifische Mahlzeit des Subjekts, die als Teil der subjektspezifischen Eingabe bereitgestellt ist, umfasst.
  8. Gastrointestinales Behandlungssystem nach Anspruch 5 oder Anspruch 6, wobei zumindest eines von der Kapsel (101) und der Steuereinheit (106) einen Standortsensor (114) beinhaltet, der ausgelegt ist, um eine geografische Region zu identifizieren, in der sich die Kapsel befindet, und wobei die zumindest eine vorbestimmte Tageszeit zumindest eine regionsspezifische Mahlzeit der geografischen Region, in der sich die Kapsel befindet, umfasst.
  9. Gastrointestinales Behandlungssystem nach einem der Ansprüche 1 bis 8, wobei der programmierbare Steuermechanismus (106) ausgelegt ist, um den Agitationsvibrationsmechanismus (104) zu aktivieren, um in dem ersten vibrierenden Betriebsmodus zu der zumindest einen vorbestimmten Tageszeit nur zu arbeiten, wenn eine Mindestverzögerungsdauer zwischen Empfang der Aktivierungseingabe und der zumindest einen vorbestimmten Tageszeit verstrichen ist.
  10. Gastrointestinales Behandlungssystem nach einem der Ansprüche 1 bis 9, wobei die zumindest eine vorbestimmte Tageszeit eine Standardmittagszeit umfasst.
  11. Gastrointestinales Behandlungssystem nach einem der Ansprüche 1 bis 10, wobei die zumindest eine vorbestimmte Tageszeit eine Standardabendessenszeit umfasst.
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GBGB1805325.6A GB201805325D0 (en) 2018-03-30 2018-03-30 Gastrointestinal Treatment System Including A Vibrating Capsule And Method Of Use Thereof
GBGB1808859.1A GB201808859D0 (en) 2018-05-31 2018-05-31 Gastrointestinal treatment system including a vibrating capsule, and method of use thereof
PCT/IB2019/052529 WO2019186445A1 (en) 2018-03-30 2019-03-28 Gastrointestinal treatment system including a vibrating capsule, and method of use thereof

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